Clinical Evaluation of Acupuncture as Treatment for...

Research ArticleClinical Evaluation of Acupuncture as Treatment forComplications of Cerebrovascular Accidents: A Randomized,Sham-Controlled, Subject- and Assessor-Blind Trial

Hsien-Yin Liao,1,2 Wen-Chao Ho,3 Chun-Chung Chen,4,5 Jaung-Geng Lin,4

Chia-chi Chang,2 Liang-Yu Chen,2 De-Chih Lee,6 and Yu-Chen Lee1,2,7

1College of Chinese Medicine, Graduate Institute of Acupuncture Science, China Medical University, Taichung 404, Taiwan2Department of Acupuncture, China Medical University Hospital, Taichung 404, Taiwan3Department of Public Health, China Medical University, Taichung 404, Taiwan4College of Chinese Medicine, China Medical University, Taichung 404, Taiwan5Department of Neurosurgery, China Medical University Hospital, Taichung 404, Taiwan6Department of Information Management, Da-Yeh University, Changhua 500, Taiwan7Research Center for Chinese Medicine & Acupuncture, China Medical University, Taichung 404, Taiwan

Correspondence should be addressed to Yu-Chen Lee; [email protected]

Received 25 December 2016; Accepted 5 March 2017; Published 20 March 2017

Academic Editor: Jenny M. Wilkinson

Copyright © 2017 Hsien-Yin Liao et al.This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed arandomized, sham-controlled double-blind study to investigate it.Methods. Patients with first-time acute stroke were randomizedto receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was changein National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI),Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS)for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (𝑛 = 28) or placebo (𝑛 = 24), 10patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients inthe acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantlygreater in the acupuncture group than in the control group (𝑝 value = 0.04). There were no significant differences in the othermeasures between the two groups.Conclusions. Acupuncture providedmore effective poststroke pain relief than sham acupuncturetreatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

1. Introduction

Stroke is one of the most common causes of death andthe leading cause of biopsychosocial disability worldwide.Poststroke complications such as death, loss of motor func-tion, daily life dysfunction, depression, and shoulder painare common [1]. Although intra-arterial thrombolysis [2],intravenous tissue plasminogen activator [3, 4], and otheradvanced therapies [5] can reduce the incidence of seriouspostcomplications when performedwithin the first few hoursof symptom onset, no single therapy has been shown toprevent all complications.

Acupuncture is commonly used in Asian countries tomanage poststroke complications, and numerous studies onits effectiveness have been conducted. However, the efficacyof acupuncture as treatment for stroke-related complicationshas been questioned because only a limited number of well-designed clinical trials have been published. For example, ina recent meta-analysis of eight randomized controlled trials,Park et al. found that the methodological quality of those tri-alswas inadequate to determine the efficacy of acupuncture astreatment for spasticity after stroke [6]. Other meta-analyseshave concluded that acupuncture has no beneficial effecton poststroke paralysis [7, 8]. However, some analyses have

HindawiEvidence-Based Complementary and Alternative MedicineVolume 2017, Article ID 7498763, 10 pageshttps://doi.org/10.1155/2017/7498763

https://doi.org/10.1155/2017/7498763

2 Evidence-Based Complementary and Alternative Medicine

Allocation

Enrollment

Follow-up

Analysis

Patient with first-time acute stroke (n = 171)

Declining to participate (n = 9)

Exclude: not meeting inclusion criteria (n = 110)

Sign informed consent and accepted simple randomization (n = 52)

(i) Received allocated intervention (n = 28)Acupuncture (n = 28)

(2) Drop-out by patients’ free will

(1) SAE (recurrent stroke, n = 1)

Exclude (n = 10)

(b) Withdrawing consent during the course (n = 4)

(a) Transfer to other hospitals or nursing home (n = 5)

n = 28 are usable for intention to treat

(ii) Withdrew consent before the course (n = 4)

(i) Received allocated intervention (n = 20)

Sham acupuncture (n = 24)

n = 20 are usable for intention to treat(i) Exclude: Withdrawing consent before the course (n = 4)

(2) Drop-out by patients’ free will(a) Transfer to other hospitals or nursing home (n = 3)

(1) SAE (recurrent, n = 2)

Exclude (n = 5)

Figure 1: Flow diagram of patient screening in this study.

demonstrated that acupuncture can improve cognitive func-tion and decrease depressive symptoms after stroke [9, 10].

Few studies have employed well-designed protocol orwell-established scales to qualitatively measure the effect ofacupuncture on biopsychosocial complications after stroke.We, therefore, designed a subject- and assessor-blinded,randomized sham-controlled clinical trial to assess whetheracupuncture is an efficacious treatment modality for post-stroke neurologic symptoms using the National Institute ofHealth Stroke Scale, activities of daily living using the BarthelIndex and Instrumental Activities of Daily Living Scale,depressive symptoms using the Hamilton Depression Ratingscale, and pain severity using the Visual Analogue Scale inpatients with recent first-time stroke.

2. Methods

2.1. Ethics. The study was conducted in accordance withthe Declaration of Helsinki. The study was approved by theResearch Ethics Committee of the China Medical UniversityHospital, Taichung, Taiwan (Protocol ID: CMUH102-REC2-015). The study was also registered on ClinicalTrials.govbefore commencement (NCT02197663).

2.2. Study Design. This was a randomized, sham-controlled,subject- and assessor-blind, single-center exploratory clinicaltrial to investigate the efficacy of 24 sessions of acupuncture astreatment for complications associated with cerebrovascularaccidents. A flowchart outlining patient selection and ran-domization procedures is shown in Figure 1.

2.3. Participants. We had an interview with new strokepatients. During these talks, we checked their response. Ifpatients were unable to cooperate or follow directions forthe assessments and tests of our study, they were excluded.Other patients who met the inclusion criteria were given fulldetails of the study in both oral and written form. If thepatients agreed to join our study, they needed to sign theinformed consent before the beginning of the study. If theywere handicapped with limbs weakness, the procedure ofsignature could be helped by their family.

All patients with first-time incident stroke who wereadmitted to the Neurological, Neurosurgical, Physical Medi-cine and Rehabilitation, or ChineseMedicine Departments atthe ChinaMedical University Hospital were considered eligi-ble for recruitment. A diagnosis of first-time and recent (1∼2weeks) stroke was based on clinical findings and definitive

https://clinicaltrials.gov/ct2/show/NCT02197663?term=NCT02197663&rank=1

Evidence-Based Complementary and Alternative Medicine 3

brain computed tomographic (CT) or magnetic resonance(MR) imaging evidence of ischemic or hemorrhagic stroke.Patients were excluded from participating in the study if theyhad a history of previous stroke or a history of other seriousdiseases such as cancer, dementia, heart failure, chronicobstructive pulmonary disease, liver cirrhosis, or kidneyfailure.

After western physicians confirmed that the vital signs ofnew stroke patientswere relatively stable, both randomizationand first-time intervention were conducted within one weekafter stroke was diagnosed.

2.4. Sample Size. The sample size was determined basedon an effect size of 𝑑 = 0.833 to detect significance of theintervention effect on the primary outcomemeasure, namely,change inNIHSS score, as described previously [11]. If we per-mitted a 5% chance of type I error (𝛼 = 0.05), a 20% chance oftype II error (𝛽 = 0.2), and a 20% drop-out rate, thenapproximately 30 initial participants in each group would berequired to have a sufficient sample size. All calculations wereperformed with G∗power for Windows (Version 3.1, FreeSoftware, Dusseldorf, Germany).

2.5. Randomization. Patients were allocated to receive realacupuncture or sham acupuncture following the principleof simple randomization. Lots with numbers 1∼60 wereplaced into a sealed envelope and participants were askedto draw one without looking at the number. Patients whodrew an even number were allocated to the treatment groupand those who drew an odd number were allocated to thesham acupuncture group. Only one investigator who was notinvolved in the treatment, assessment, or data analysis couldsee the number on the lots. The patients, the assessor, andbiostatistician were blinded to the allocation until the datawere analyzed.

2.6. Intervention Group (Acupuncture). A single practitionerof Chinese Medicine with more than 15 years of experiencein acupuncture performed all of the interventions. Manualacupuncturewas carried out in patients in the supine positionand comprised both body and scalp acupuncture for a totalof 20 minutes per session 3 times per week for a total of 24sessions.The following acupoints were needled in all patients:Baihui (GV-20), Sishencong (EX-HN1), temporal three-needle technique (Jin three-needle therapy, one side for theweakness limbs), Quchi (LI11), Hegu (LI4), Neiguan (PC6),Waiguan (TE5), Yanglingquan (GB34), Zusanli (ST36), Sany-injiao (SP6), and Taichong (LR3). Other acupoints wereneedled based on each patient’s symptoms, such as SpeechII or Speech III areas (Jiao’s Scalp Acupuncture) for aphasia,Jinjin (EX-HN 12) and Yuye (EX-HN 13) for dysarthria,and Fenglung (ST40) and Chizexue (LU5) for sputum. Eachacupoint was stimulated to elicit a needle sensation (de qi)and needling depth was based on the excitation of de qi.All procedures were carried out with disposable needlesmeasuring 0.25mm in diameter (32-gauge) and 44mm inlength (Yu Kuang, Taipei, Taiwan).

2.7. Control Group (Sham Acupuncture). Participants in thesham group also received 24 sessions of acupuncture treat-ment; however, needling was performed 1 cm away from thereal acupoints. In addition, none of the participants in thesham group received scalp acupuncture. All procedures werecarried out to a depth of 0.5 cm with disposable needlesmeasuring 0.16mm in diameter (40-gauge) and 12.7mm inlength (Yu Kuang, Taipei, Taiwan). No needle sensation (deqi) was elicited.

Patients in both groups also received conventional west-ern rehabilitation with the same frequency and receivedwestern medications as needed during inpatient admissionand outpatient tracking.

2.8. OutcomeMeasures. Assessments were carried out beforetreatment (baseline) and at the end of the 8th, 16th, and 24thtreatment session by a single trained, certified, and blindedresident physician.

2.9. Primary Outcome Measure. The primary outcome waschange in the National Institute of Health Stroke Scale(NIHSS), a well-established measure of stroke severity.

2.10. Secondary. Secondary outcome measures includedchanges in Barthel Index (BI, Mahoney and Barthel Version),Instrumental Activities of Daily Living (IADL, Lawton, M.P., & Brody, E. Version), Hamilton Depression Rating Scale(HAM-D, 24-item Version), and Visual Analogue Scale forpain (VAS) scores. We used the VAS to assess the severityof pain caused by muscle spasticity, limbs hemiplegia, andhemiparesis. Severity of central poststroke pain such asburning, throbbing, or shooting pain was not assessed.

2.11. Incidence of Severe Adverse Events. The majority ofpotential acupuncture-related adverse events are not life-threatening and have documented low incidence rates such aslocal bleeding (<1%), haematoma (<3%), dizziness (<1%),fainting (<1%), and pain (<10%) [11, 12]. Therefore, in thisstudy, onlymajor adverse events such as recurrent strokewereincluded in the analysis.

2.12. Statistical Analysis. Baseline characteristics areexpressed as mean ± standard deviation for continuous var-iables or as percentages for categorical variables. Thechi-square test was used for categorical comparisons ofdata. Between-group differences in primary and secondaryoutcome measures are expressed as mean ± standarddeviation and were tested by the Mann–Whitney 𝑈 test.For within-group comparisons, the Wilcoxon signed-ranktest was used. A 𝑝 value < 0.05 was considered to indicatestatistical significance. All statistical analyses were carriedout using the statistical package SPSS for Windows (Version21.0, SPSS, Chicago, Illinois, USA).

The analyses were performed on an intention-to-treatbasis, with missing data replaced by the principle of lastobservation carried forward.


Table 1: Baseline characteristics of randomized subjects.

Acupuncture (𝑛 = 28) Sham acupuncture (𝑛 = 20) 𝑝 valueMale, 𝑛 (%) 19 (67.86%) 11 (55.00%) 0.385Female, 𝑛 (%) 9 (33.33%) 9 (45.00%)Image finding: infarct, 𝑛 (%) 14 (50%) 17 (80%)

0.016∗

Image finding: hemorrhage, 𝑛 (%) 14 (50%) 3 (20%)Hypertension, 𝑛 (%) 22 (78.57%) 13 (65.00%) 0.34Diabetes, 𝑛 (%) 5 (17.86%) 6 (30.00%) 0.49Heart disease, 𝑛 (%) 5 (17.86%) 4 (13.30%) 1.00Hyperlipidemia, 𝑛 (%) 0 (0.00%) 1 (5.00%) 0.42Age (mean ± SD) 62.29 ± 12.33 55.45 ± 15.22 0.09Height (mean ± SD) 162.36 ± 7.58 163.03 ± 8.50 0.78Weight (mean ± SD) 64.56 ± 9.67 68.84 ± 11.95 0.18Prescore of Barthel Index (mean ±SD) 59.64 ± 41.94 65.75 ± 34.08 0.93

Prescore of Instrumental Activitiesof Daily Living (male) (mean ± SD) 2.63 ± 2.52 2.55 ± 2.21 1.00

Prescore of Instrumental Activitiesof Daily Living (female) (mean ±SD)

3.8 ± 3.5 3.4 ± 2.5 1.00

Prescore of National Institutes ofHealth Stroke Scale (mean ± SD) 6.00 ± 5.84 6.93 ± 5.75 0.22

Prescore of Hamilton DepressionRating Scale (mean ± SD) 13.94 ± 11.27 12.6 ± 6.34 0.62

Prescore of Visual Analogue Scalefor pain (mean ± SD) 1.56 ± 2.97 1.47 ± 2.29 0.68

3. Results

3.1. Recruitment and Severe Adverse Events. Figure 1 sum-marizes the patient selection, recruitment, and exclusionprotocols of the trial. Of the 171 patients with first-time strokewho presented to the CMUH during the period June 2014to October 2015, 61 met the inclusion criteria and 52 ofthemprovided signed informed consent to participate.The 52patients were randomly assigned to receive real acupuncture(𝑛 = 28) or sham acupuncture (𝑛 = 24). However, afterallocation, 4 patients in the placebo group withdrew con-sent to participate and were, therefore, excluded from theanalysis. During the 8-week treatment period, 3 patientswere withdrawn from the trial because of recurrent stroke(1 in the acupuncture group and 2 in the sham group) and12 dropped out for personal reasons (9 in the acupuncturegroup and 3 in the sham group), including transfer to otherinstitutions (𝑛 = 5 and 𝑛 = 3, resp.) and withdrawal ofconsent (4 in the acupuncture group). Therefore, 18 patientsin the acupuncture group and 15 patients in the sham groupcompleted the treatment course. However, for intention-to-treat purposes, data on 28 participants in the acupuncturegroup and data on 20 participants in the sham group wereavailable for analysis.

3.2. Baseline Data. Baseline data are presented in Table 1.There were no significant differences in baseline characteris-tics between the two groups of patients with the exception ofstroke type.The incidence of ischemic strokewas significantly

higher in the sham group than in the acupuncture group andthe incidence of hemorrhagic stroke was significantly higherin the acupuncture group than in the sham group.

3.3. Drop-Out Rate and Drop-Out Data Analysis. As seenin Figure 1, the drop-out rates were 32.14% (9/28) in theacupuncture group and 29.17% (7/24) in the sham group. Noone dropped out due to the design or execution of the trial.

3.4. Primary and Secondary OutcomeMeasures. By analyzingthe data after 8th and 16th treatment sessions, we found nosignificant between-group differences and decided to presentthe data of baseline and the end.

As shown in Figures 2(a), 2(b), and 3(a), intragroupcomparisons revealed that both acupuncture group and shamacupuncture group had significant improvements in NIHSS,Barthel Index, and HAM-D scores. However, there were nosignificant differences in improvement in scores between thetwo groups.

As shown in Figure 2(c), there were no significant inter-group or intragroup differences in scores on the IADL scale.Interestingly, however, significant intragroup improvementin IADL scale was noted for women who received shamacupuncture.

As shown in Figure 3(b), reduction in pain was signifi-cantly greater in the acupuncture group than in the controlgroup (𝑝 = 0.04).

Whole results of all scales were shown as Table 2.


0102030405060708090

100

AcupunctureSham

Bart

hel I

ndex

Pretest Difference (post-pre)Posttest

∗

∗

(a)

02468

1012

AcupunctureSham

42


∗

∗

Nat

iona

l Ins

titut

es o

f Hea

lth S

troke

scal

e(b)

3


Acupuncture (male)Acupuncture (female)

Sham (male)Sham (female)

0123456789

Inst

rum

enta

l Act

iviti

es o

f Dai

ly L

ivin

g Sc

ale

∗

(c)

Figure 2: (a) Effect of acupuncture and sham acupuncture on BI, ∗𝑝 < 0.05. (b) Effect of acupuncture and sham acupuncture on NIHSS,∗𝑝 < 0.05. (c) Effect of acupuncture and sham acupuncture on IADL, ∗𝑝 < 0.05.

4. Discussion

In this study, we found no significant differences in changein NIHSS, BI, IADL, or HAM-D scores between patientswho received real acupuncture and those who received shamtreatment.The high drop-out rate is one of the possible causesfor that finding. The attrition rate was estimated to be 20%;however, the rates were 28.57% in the acupuncture group and29.17% in the sham group. One of the reasons for the higherthan expected attrition rates was the relatively high numberof acupuncture sessions (𝑛 = 24) required to completethe trial. Patients who were transferred to other hospitalsfor western treatment during the trial might have found itinconvenient to return to the CMUH to receive our treatmentdue to either distance or time constraints and, therefore,

dropped out of the study. Liu et al. found that acupuncturedid not have a beneficial effect on stroke recovery and thatthe lack of effect might have been because the assessmentsof the effect were conducted too soon after the occurrenceof stroke, in most cases 2-3 weeks after stroke [13]. That wasthe reason why we designed the trial to include 24 treatmentsessions. Another possible reason for the lack of better effectof acupuncture on themajority of poststroke complications isthat patients in both groups underwent conventional westernrehabilitation and were given western medications as neededduring inpatient admission and outpatient tracking, whichmay have introduced bias. In addition, the effect of westerntreatment might have masked or minimized the between-group differences in all scales. A third reason is due, at leastin part, to our limited research resources; we were unable to


42

AcupunctureSham


05

10152025

Ham

ilton

Rat

ing

Scal

e for

Dep

ress

ion

∗

∗

(a)

10

AcupunctureSham


0

1

2

3

4

5

Visu

al A

nalo

g Sc

ale f

or p

ain

∗

(b)

Figure 3: (a) Effect of acupuncture and sham acupuncture on HAM-D, ∗𝑝 < 0.05. (b) Effect of acupuncture and sham acupuncture on VAS,∗𝑝 < 0.05.

Table 2: Comparison of NIHSS, Barthel Index, IADL, HAM-D, and VAS scores between two groups.

Group assessment Acupuncture Sham 𝑝 value (between-group)Pretest Posttest Pretest Posttest Pretest Posttest

NIHSS 6.00 ± 5.84 3.82 ± 4.95 5.95 ± 5.45 3.55 ± 4.63 0.67 0.97NIHSS difference −2.18 ± 3.32 −2.40 ± 2.62 0.59Barthel Index 59.64 ± 41.94 73.04 ± 35.23 65.75 ± 34.08 78.00 ± 31.72 0.93 0.60BI difference 13.39 ± 25.57 12.25 ± 19.50 0.40IADL (male) 2.63 ± 2.52 2.79 ± 2.62 2.55 ± 2.21 3.27 ± 2.05 1.00 0.70IADL (male) difference 0.16 ± 0.50 0.73 ± 1.12 0.42IADL (female) 4.22 ± 3.77 5.44 ± 3.25 3.89 ± 2.98 5.67 ± 3.00 1.00 0.93IADL (female) difference 1.22 ± 1.92 1.78 ± 2.279 0.73HAM-D 13.94 ± 11.27 6.22 ± 6.61 12.60 ± 6.34 6.53 ± 5.80 0.62 0.50HAM-D difference −7.72 ± 8.37 −6.07 ± 7.11 0.97VAS 1.56 ± 2.97 0.44 ± 1.83 1.47 ± 2.29 1.73 ± 2.15 0.68 0.04∗

VAS difference −1.11 ± 2.54 0.27 ± 2.11 0.53Wilcoxon signed rank test was used. ∗𝑝 < 0.05.NIHSS: National Institutes of Health Stroke Scale; BI: Barthel Index; IADL: Instrumental Activities of Daily Living; HAM-D: Hamilton Depression RatingScale; VAS: Visual Analogue Scale for pain.

recruit enough patients to achieve the minimal sample sizeneeded to detect significance of the intervention effect on theprimary outcome measure, namely, change in NIHSS.

Two types of pain are common poststroke complications.One is central poststroke pain and the other is hemiplegicshoulder pain, which impacts the limb motor function,disturbs the rehabilitation process, extends the length ofhospitalization, and affects the patient’s quality of life. Becausewe excluded central poststroke pain at first, lots of the painas our study showed are hemiplegic shoulder pain and fewerare pain from affected lower limbs. Previous study has shownthat spastic symptoms can induce pain, ankylosis, tendonretraction, or muscle weakness [14]. Besides, hemiplegicshoulder pain affects 16–84% of impaired stroke survivors

[15]. Even though there are lots of therapies such as physio-therapy, massage, strapping, slings, intraarticular or subacro-mial corticosteroid injections, suprascapular nerve blocks,percutaneous or superficial electricalmuscle stimulation, andintramuscular botulinum toxin type A injections, there isno specific evidence for most of these treatments [16]. Ourtrial focused on the pain caused by spasticity and showedthat acupuncture is effective at reducing the severity of limbpain. Two recent systematic reviews also concluded thatacupuncture is an effective treatment modality for poststrokeshoulder pain [17] and spasticity [18]. The obvious between-group difference in posttest VAS scales might indirectly showthat acupuncture results in a reduction in the degree of paincaused by spasticity.


Table 3: Summary and comparison of randomized sham-controlled trials of acupuncture for global functional recovery after stroke (acuteto subacute stage).

Study Studydesign

Patientpopulation

Experimentaltreatment

Controltreatment

Therapist/sessionof course

Assessor/ITT orPP/outcome measures Intergroup differences

Naeser etal. 1992[19]

Double-blind,parallel2-arm

𝑛 = 16,1–3mth afterinfarctionFresh case?

(A) (𝑛 = 10)Acupuncture +elec-troacupunc-ture and scalpacupuncture

(B) (𝑛 = 6)Shamacupuncture(penetrating) +sham electricalstimulation(electricalstimulation notconducted)

Therapists?20 times

Within 4wks

3 assessors notbelonging to ITT orPP?(1) Boston MotorInventory(2) Boston MotorInventory withanalysis of CT scan oflesion site

Significantlydependent on CTscan lesion site

Gosman-Hedstromet al. 1998[21]

Single-blind,parallel3-arm

𝑛 = 104,<1 wk afterstroke Fresh

case?

(A) (𝑛 = 37)(electrical +manual)Acupuncture +conventionalstrokerehabilitation

(B) (𝑛 = 34)Superficialacupuncture, no“de chi” +conventionalstrokerehabilitation(C) (𝑛 = 33)Conventionalstrokerehabilitation

4 therapists20 times

Within 10wks

2 assessor intention totreat(1) ScandinavianNeurological StrokeScale(2) Barthel ADLIndex(3) Sunnaas ADLIndex(4) NottinghamHealth Profile

Not significant

Johanssonet al. 2001[22]


𝑛 = 1505∼10 d afterstroke Fresh

case?

(A) (𝑛 = 48)Acupuncture +elec-troacupunc-ture +conventionalphysiotherapy(B) (𝑛 = 51)High-intensity,low-frequencyTENS +conventionalphysiotherapy

(C) (𝑛 = 51)Low-intensity,high-frequencyTENS +conventionalphysiotherapy

Therapists from 7university anddistrict hospitals

20 timesWithin 10wks

1 assessorintention to treat(1) Barthel Index(2) RivermeadMobility Index(3) Nine-Hole PegTest(4) NottinghamHealth Profile

Not significant

Park et al.2005 [20]


𝑛 = 116,<4wk afterstroke Fresh

case

(A) (𝑛 = 56)Acupuncture

(B) (𝑛 = 60)Shamacupuncture(nonpenetratingonnonacupuncturepoints)

1 therapist9–12 times

Within 2wks

4 assessors intentionto treat(1) Barthel ADL Index(2) NIHSS(3) Motoricity Index(4) EQ-5D(5) NottinghamExtended Activities ofDaily Living(6) ModifiedAshworth Scale

Not significantExcept a greaterimprovement in legfunction

Schuler etal. 2005[23]


𝑛 = 120,3–35 d afterstroke Fresh

case?

(A) (𝑛 = 41)Acupuncture +electricalstimulation

(B) (𝑛 = 40)Sham elec-troacupuncture(surfaceelectrodes onacupuncturepoints withvisualstimulation)(C) (𝑛 = 39)Control (noadditionaltreatment)

3 therapists8 times

Within 4wks

Assessors?Intention to treat(1) European StrokeScale(2) Barthel Index

No differences


Table 3: Continued.

Study Studydesign

Patientpopulation

Experimentaltreatment

Controltreatment

Therapist/sessionof course

Assessor/ITT orPP/outcome measures Intergroup differences

Hopwoodet al. 2008[24]


𝑛 = 105,4–10 d afterstroke Fresh

case

(A) (𝑛 = 57)Acupuncture +elec-troacupunc-ture and scalpacupuncture

(B) (𝑛 = 48)Sham TENS(with no currentflow)

therapists from 5general hospitalsin Hampshire(UK) 12 timesWithin 4wks

assessment nursesintention to treat(1) Barthel Index(2) Motoricity Index(3) NottinghamHealth Profile

no significantdifference Exceptimprovement in theMI

Shen et al.2012 [11]


𝑛 = 290,24 hr–14 dafter acuteischemic

stroke Freshcase

(A) (𝑛 = 145)Acupuncture +medicaltreatment

(B) (𝑛 = 145)Shamacupuncture(nearby theacupoints) +medicaltreatment

Therapists of 4hospitals28 times

Within 4wk

A research nurseITT or PP?(1) Barthel Index(2) Relapse(3) Death(4) NIHSS(5) Chinese StrokeScale(6) Oxford HandicapScale(7) Stroke SpecificQuality of Life Scale

(1) 𝑝 = 0.01(2) 𝑝 = 0.001(3) 𝑝 = 0.558(4) 𝑝 < 0.01(5) 𝑝 < 0.001(6) Intervention <control(7) 𝑝 < 0.01

Zhu et al.2013 [25]


𝑛 = 188<30 d afterstroke Fresh

case

(A) (𝑛 = 98)Acupuncture(body andscalp) +conventionalphysiotherapy

(B) (𝑛 = 90)Conventionalphysiotherapy

4 acupuncturistsand 4

physiatrists?From 4

rehabilitationcenters 42.6 times

of bodyacupuncture and22.5 times of scalp

acupuncturewithin 3mths

4 physiatristsIntention to treat(1) Fugl-MeyerAssessment(2) Barthel Index

No significantdifference

Zhang etal. 2015[12]

Single-blinded,parallel2-arm

𝑛 = 8623–10 d afterischemic

stroke Freshcase?

(A) (𝑛 = 427)Acupunctureplus standardcare

(B) (𝑛 = 435)Standard care

Acupuncturists ofmulticenter (40hospitals) 20

timesWithin 4wks

Assessors?Intention to treat(1) ScandinavianStroke Scale(2) Barthel Index

No significantdifference

Our study


𝑛 = 52,1∼2wk

After strokeFresh case

(A) (𝑛 = 28)Acupuncture(body andscalp) +conventionalphysiotherapy

(B) (𝑛 = 24)Shamacupuncture(superficial, notacupoints andno “de chi”) +conventionalphysiotherapy

1 therapist, 24times

Within 8wks

1 assessorIntention to treat(1) NIHSS(2) Barthel Index(3) InstrumentalActivities of DailyLiving(4) Hamilton RatingScale for Depression(5) Visual AnalogueScale for pain

(1) 𝑝 = 0.97(2) 𝑝 = 0.60(3) 𝑝 = 0.70male𝑝 = 0.93 female(4) 𝑝 = 0.50(5) 𝑝 = 0.04

TENS: transcutaneous electrical nerve stimulation; NIHSS: National Institutes of Health Stroke Scale; d: day; wk: week; mth: month.World Health Organization Quality of Life BREF (WHOQOL-BREF); ITT: intention to treat; PP: per-protocol.

Furthermore, to highlight the value of our study, wesearched for clinical trials of acupuncture for global func-tional recovery from acute to subacute stage of stroke con-ducted during the period 1992 to 2016 and identified ninestudies with relatively good methodological quality. Table 3provides a summary and comparison of these trials. Amongthose nine trials, three were adequately designed subject-and-assessor-blind studies with a low degree of performance

bias [11, 19, 20]. In our subject-and-assessor-blind trial,we minimized potential bias by excluding patients withrecurrent stroke, unlike the trials conducted by Naeser et al.,Gosman-Hedstrom et al., Johansson et al., and Schuler et al.Furthermore, our use of only one therapist and one blindassessor furtherminimized treatment and detection bias.Thenumber of acupuncture sessions in our study (𝑛 = 24)conducted over an eight-week period was markedly higher


than in most other trials, allowing us to more accuratelymeasure the accumulation effect of acupuncture on stroke-related complications. As in most of the previous trials onthe effect of acupuncture in stroke patients, our trial usedintention-to-treat to avoid attrition bias when analyzing data.In addition, as in most trials, we found that acupunctureresulted in modest improvement in some of the outcomemeasures, such as the Visual Analogue Scale for pain.

5. Conclusion

Acupuncture provided more effective poststroke pain reliefthan sham acupuncture treatment in the subacute phaseof stroke. However, acupuncture was not superior to shamtreatment for recovery of neurological function, activities ofdaily living, or depression. Further studies involving largersample sizes and more treatment sessions are warranted.

Abbreviations

NIHSS: National Institutes of Health Stroke ScaleBI: Barthel IndexIADL: Instrumental Activities of Daily LivingHAM-D: Hamilton Depression Rating ScaleVAS: Visual Analogue Scale for painSAE: Severe Adverse EventsCMUH: China Medical University Hospital.

Conflicts of Interest

The authors declare no conflicts of interest.

Acknowledgments

This study was supported by China Medical Universityunder the Aim for Top University Plan of the Ministry ofEducation, Taiwan, and The Taiwan Ministry of Health andWelfare Clinical Trial and Research Center of Excellence(MOHW105-TDU-B-212-133019).

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